Trial to Evaluate Safety, Tolerability, Efficacy of PerioSept® as Adjunct to SRP in Subjects With Periodontitis

• Status: Completed
• Trial end date: 2020-09-25
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 2, uncontrolled, open-label, single arm study to evaluate the safety, tolerability and efficacy of PerioSept® (3%) as adjunct to Scaling and Root Planing in subjects with periodontitis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Geistlich Pharma AG
• Treatments: Taurolidine

Criteria

Inclusion Criteria:

• Subjects male or female 18 to 80 years of age, inclusive.

• Subjects must be diagnosed with moderate to severe generalized periodontitis (ADA Classification Case Type III or IV) as determined by the investigator.

• Subjects must have at least 4 qualifying target teeth (having a dental pocket with PPD ≥ 6mm and BOP) (teeth having no endodontic disease - treated or untreated).

• Subjects must have at least 12 teeth in the functional dentition, excluding second and third molars In subjects with limited dentition, tooth loss should not be due to traumatic occlusion

• Females of childbearing potential must agree to use of birth control (hormonal, barrier method or abstinence). Hormonal contraceptives must have started not fewer than 30-days before baseline visit/Day 1.

• Subjects must sign informed consent document(s) prior to initiation of any study-specific procedures and treatments.

• Subjects who are able and willing to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

• History of and/or known risk of life-threatening anaphylactic reactions to taurolidine, any of the components in the investigational drug product.

• Presence of an acute periodontal abscess.

• Subjects with healing disorders (e.g. uncontrolled diabetes mellitus, oral cancer) that could compromise wound healing and/or preclude periodontal surgery.

• Subjects who are taking medications that compromise wound healing presenting with clinical evidence of secondary hyperplastic gingival tissue reactions (e.g. calcium channel blockers or anti-seizure medications)

• Pregnant or nursing female subjects; women of child-bearing potential must have a negative urine pregnancy test.

• Use of systemic antibiotics and, topically applied oral antibiotics and other antimicrobial agents (e.g., chlorhexidine) within 45 days prior to Day 1 or expected use during the study trial period.

• An existing condition that may warrant use of antibiotics during the study trial period.

• Known Human Immunodeficiency Virus infection or other immunodeficiency syndrome.

• Subjects with active infectious diseases (e.g. hepatitis, HIV or tuberculosis)

• Use of agents known to affect periodontal status during the trial and/or use within 45 days prior to Day 1 e.g. immunosuppressants, nasal or oral corticosteroids, calcium channel blockers, phenytoin or anticoagulants.

• Heavy smokers/tobacco users are excluded: defined as those smoking ≥ 10 cigarettes or ≥ 4 cigars or ≥ 4 pipes per day (smokeless nicotine products are NOT excluded)

• Participation in another clinical study with an investigational agent within 90 days prior to Day 1.

• Subjects who received oral health treatments/interventions within 90 days of Day 1, which the investigator believes may interfere with the periodontal parameters to be assessed in this study (e.g., significant dental and/or gum/oral tissue work).

• SRP or periodontal surgery within 12 months prior to Day 1.

• Subject who have a medical and/or dental condition (e.g. a current clinically unstable occlusal situation) and/or use medications/supplements which the investigator believes makes him/her unsuitable for participation in the study